Actively Recruiting
Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody (The SAMBA Study)
Led by Aarhus University Hospital · Updated on 2024-10-31
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
C
Charite University, Berlin, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
Hepatitis B virus (HBV) remains a major global health problem with an estimated 257 million people living with the infection worldwide. Chronic HBV (CHB) is a major cause of liver cirrhosis and hepatocellular carcinoma. While antiviral therapies are available and suppress viral levels, treatment is long-term, does not clear the infection and rarely leads to long-term control once discontinued. Moreover, treatment access is not ideal on a global level with less than 10% of people in need receiving treatment. Although a strategy that eliminates all viral particles from the body represents the "holy grail" of HBV therapy, a strategy that leads to HBsAg loss and allows patients to stop treatment is highly desirable. New strategies to achieve either complete viral clearance or a state of viral control without the need for long-term treatment are being developed, including approaches to restore immune responses. Antibodies are key modulators of immune responses because of their dual functionality. In addition to directly targeting a viral antigen, antibodies differ from direct antivirals in that they can recruit other immune cells to eliminate infected cells and accelerate viral clearance. This study will evaluate the safety and pharmacokinetics of a monoclonal antibody that was isolated from an HBV-vaccinated individual, HepB mAb19, as well as its potential effects on viral levels and antiviral immune responses in individuals living with CHB.
CONDITIONS
Official Title
Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody (The SAMBA Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Confirmed chronic hepatitis B infection with positive HBsAg for at least 6 months
- On HBV-active nucleos(t)ide therapy for at least 6 months without changes in the previous 3 months
- HBV DNA below lower limit of quantification 49 days before study entry
- Negative HBs antibody and HBeAg negative
- Ability and willingness to provide informed consent
- For participants who can become pregnant: negative pregnancy test at screening and day 0
- Participants who can become pregnant must use two methods of contraception, including one highly effective method, starting 10 days before study entry and during follow-up
- Participants who can impregnate a partner must agree to use condoms starting 10 days before study entry and during follow-up
You will not qualify if you...
- Signs or diagnosis of advanced liver fibrosis (FibroScan result <9 kPa) within 12 months before entry or at pre-infusion visit
- Presence of liver lesions classified as LI-RADS4 or 5 within 12 months before entry or at pre-infusion visit
- Alpha fetoprotein level >20 ng/ml, unless earlier levels were normal and recent imaging negative
- Infection with HIV-1, HCV, or hepatitis delta virus within 12 months before entry or at screening
- History of hematopoietic stem cell or solid organ transplant
- Significant allergic reactions to drugs, monoclonal antibodies, vaccines, or multiple drug allergies
- History of cardiovascular disease or significant ECG abnormalities
- Use of systemic corticosteroids, immunosuppressive anti-cancer agents, systemic interferons, or interleukins within 6 months before entry
- Chronic liver disease from other causes or autoimmune diseases that would interfere with participation
- Significant acute infections or illnesses within 2 weeks before entry
- Laboratory abnormalities: neutrophil count <1000/mm3, hemoglobin <10 g/dL, platelet count <150,000/mm3, ALT or AST >2x upper normal limit, total bilirubin >1.5x upper normal limit (except Gilbert's), albumin <3.5 g/dL, eGFR <70 mL/min, INR ≥1.2
- Pregnancy or breastfeeding
- Vaccination within 2 weeks before entry
- Previous anti-HBV monoclonal antibody therapy
- Participation in another investigational study currently or within 12 weeks prior to this study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Infectious Diseases, Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
Research Team
O
Ole Schmeltz Søgaard, MD, Professor
CONTACT
T
Thomas Rasmussen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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